BEUDAMED
    FDA Enforcement Class II Terminated

    SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue

    Recall: Z-2047-2014 · Reported July 23, 2014

    Enforcement

    Recall Number
    Z-2047-2014
    Event ID
    68565
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smith & Nephew, Inc. Endoscopy Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    July 23, 2014
    Initiation Date
    June 2, 2014
    Classification Date
    July 14, 2014
    Termination Date
    September 15, 2017
    Address
    150 Minuteman Drive, N/A, Andover, MA, 01810-1031, United States

    Description

    SUTUREFIX Ultra S with 1 #2 Ultrabraid (blue) Product Code: 72203852 Fastener, fixation, nondegradable, soft tissue

    Reason

    Sterility of device is compromised due to breach in sterile barrier

    Code Info

    Lot Numbers: 50478982, 50478985, 50482873, 50485588, 50486705, 50486707, 50491897, 50491899

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Australia, Belgium, Denmark, France, Germany, Great Britain, Italy, Netherlands, Norway, Portugal, Spain, and Sweden.

    Quantity

    907 units